NCT01385553

Brief Summary

Social service systems rarely acknowledge the status of men as fathers in the conceptualization and delivery of treatment for substance abuse or domestic violence. Although there has been extensive focus on the treatment of mothers who abuse substances, are victims of intimate partner violence (IPV) (defined as physical aggression and/or psychological abuse and control at the hands of an intimate partner), or maltreat their children there has been little consideration of the need for interventions for fathers with histories of co-morbid IPV and substance abuse. It is estimated that between 10 and 17.8 million children are witness to violence in their homes each year. National and regional samples indicate 50-70% of families impacted by IPV and the typically co-occurring substance abuse have children under the age of seven. Large percentages of these men continue to live with or have consistent contact with their young children despite aggression and substance use. Court mandated treatments for perpetrators of domestic violence have become the norm, however the efficacy of these treatments is questionable and most do not speak to the broader needs of batterers and their families. How batterer's treatments might impact parenting and father-child relationships and the psychosocial functioning of children is vastly understudied and not currently understood. Since batterer treatments are court mandated and require tremendous financial and community resources, the efficacy of these interventions in stopping the cycle of domestic violence and improving the health and well-being of the batterer, his partner and children is crucial. There are currently NO evidence-based treatments that address co-morbid substance abuse and domestic violence perpetration with emphasis on paternal parenting and the father-child relationship. Consequently, the proposed psychotherapy development project will develop and evaluate the potential efficacy of a novel, relational parent intervention for fathers with co-morbid substance abuse and IPV who have young children. The goals of this intervention are to decrease aggression and substance abuse by increasing focus on fathering and an improved father-child relationship.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

June 14, 2011

Last Update Submit

February 18, 2014

Conditions

Outcome Measures

Primary Outcomes (3)

  • Decrease in Verbal and Physical Aggression

    Conflict Tactics Scale and the TimeLine Follow-back calendar interview

    Baseline (Start of Tx), 4 month follow-up, 7 month follow-up

  • Decrease in Substance Abuse

    urinalysis results and self report

    weekly for months 1-4, 7 month followup

  • Decrease in Negative Parenting Behavior

    IOWA, Adult child relationship questionnaire, Parental Acceptance Rejection Questionnaire

    baseline, 4 month, 7 month follow-up

Study Arms (2)

Individual Drug Counseling

ACTIVE COMPARATOR
Behavioral: Individual Drug Counseling

Fathers for Change

EXPERIMENTAL
Behavioral: Fathers for Change

Interventions

FATHERS FOR CHANGE comprises 16, 60 minute sessions of treatment utilizing components of three evidence based practices: SADV-Cognitive Behavioral Therapy, Behavioral Couple Therapy and Child-Parent Psychotherapy. The goals of the intervention are: 1) decreased substance abuse and IPV by teaching coping and anger management skills, 2) improved communication and increased problem solving around shared parenting 3) parenting education including child development and the impact of violence on children, 4) discussion of discipline practices and development of behavior modification or positive reinforcement plans, and 5) attachment focused parent-child play sessions to coach fathers in play with their children and process traumatic experiences.

Also known as: Integrated Father Treatment for Domestic Violence
Fathers for Change

Individual drug counseling focuses on the symptoms of drug addiction and related areas of impaired functioning and the content and structure of the patient's ongoing recovery program. This model of counseling is time limited and emphasizes behavioral change. It gives the patient coping strategies and tools for recovery and promotes 12-step ideology and participation. The primary goal of addiction counseling is to assist the addict in achieving and maintaining abstinence from addictive chemicals and behaviors. The secondary goal is to help the addict recover from the damage the addiction has caused in his or her life.

Also known as: IDC
Individual Drug Counseling

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • meet current DSM-IV criteria for substance abuse and who have used a substance within the 60 days prior to screening;
  • have a police reported incident of IPV (pushing, slapping, kicking) within 6 months of referral;
  • have at least one biological child under the age of 7 with whom they reside or have at least weekly visitation.

You may not qualify if:

  • Have histories of severe physical violence (e.g. choking, causing hospitalization);
  • Men who have an active NO CONTACT protective order pertaining to their partner or child;
  • Men whose female partners indicate that they do not want the child to participate;
  • If the female partner indicates that she believes her child is afraid of his/her father and will NOT want to participate;
  • Men who are currently in withdrawal from substances and in need of detoxification;
  • Have cognitive impairment or a lifetime history of any psychotic or bipolar disorder; or
  • Are currently suicidal or homicidal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • Easton CJ, Mandel DL, Hunkele KA, Nich C, Rounsaville BJ, Carroll KM. A cognitive behavioral therapy for alcohol-dependent domestic violence offenders: an integrated substance abuse-domestic violence treatment approach (SADV). Am J Addict. 2007 Jan-Feb;16(1):24-31. doi: 10.1080/10550490601077809.

    PMID: 17364418BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Carla S Stover, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 14, 2011

First Posted

June 30, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations